Myopia control by using an extended depth of focus contact lens

JRCT ID: jRCTs052200102

Registered date:22/12/2020

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Myopia
• Date of first enrollment: 22/12/2020
• Target sample size: 100
• Study type: Interventional
• Intervention(s): Contact lens wear

Outcome(s)

• Primary Outcome: Changes in axial length under accommodative paralysis between the baseline visit and last visit 12-month visit

Secondary Outcome

1. Changes in axial length under accommodative paralysis between the baseline visit and last visit 6-month visit
2. Changes in refraction under accommodative paralysis between the baseline visit and last visit 12-month visit
3. Visual performance at every examination visit
4. Adverse events which are observed between the baseline visit and 12-month visit and considered as those associated with of devices used in the study
5. Contrast sensitivity, ocular higher-order aberrations for 4-mm and 6-mm pupil, and axial length under accommodative paralysis

Key inclusion & exclusion criteria

• Age minimum: >= 6age old
• Age maximum: <= 12age old
• Gender: Both

Include criteria

1.6 to 12 years old when obtaining consent
2.Refractive error between -1.00 D and -6.00 D, astigmatism equal or less than 0.75D
3.The difference in spherical equivalent of the subjective refraction between both eyes is less than 1.00 D
4.Those with corrected vision of 0.8 or more in both eyes
5.Those who can consult for regular inspection
6.Those who have given written consent by voluntary will

Exclude criteria

1.Obvious abnormal eye position or overt strabismus
2.Having ocular disease that affects contact lens wear
3.Having systemic disease
4.Previous history of ocular surgery
5.Use of drugs, eye drops or supplements that would affect accommodative function
6.Receiving myopia progression prevention treatment such as bifocal glasses, multifocal contact lens, orthokeratology lens, drug treatment within 3 months
7.Judged to be inappropriate for the study subject

Related Information

• Primary Sponsor: Koh Shizuka
• Source(s) of Monetary Support: SEED Co., Ltd. Tokyo, Japan